MedImmune and CTI will collaborate on the research and development of antibodies and other drug products targeting the High Mobility Group Box Chromosomal Protein 1 (HMGB-1), which is believed to be involved in the tissue damage associated with a range of inflammatory illnesses, such as rheumatoid arthritis and sepsis. The companies plan to focus on developing drug products with the potential to block HMGB-1, which if successful, could help reduce the injury and death associ-ated with severe inflammatory diseases and infections.
"CTI's proprietary anti-HMGB-1 technology is a great fit with our core expertise in antibody technology and anti-arthritic/anti-inflammatory disease research," commented James F. Young, Ph.D., MedImmune's president of research and development. "Elevated levels of HMGB-1 are found in many acute and chronic diseases, including rheumatoid arthritis, inflammatory bowel disease, hemorrhagic shock, sepsis, endotoxemia, and acute lung injuries. We believe that treat-ment with anti-HMGB-1 antibodies or antagonists may help alleviate or prevent the severe tissue damage that often results from such afflictions."
HMGB-1 is a cytokine, which means it is one of the many hormone-like proteins secreted by dif-ferent cell types that regulate the intensity and duration of an immune response. HMGB-1 is ex-pressed at high levels beginning approximately 12 to 72 hours after an inflammatory reaction of the immune system has been initiated and at about the time tissue damage is believed to occur. Because of the timing and the duration of its expression, HMGB-1 could potentially be a more important factor than other cytokines, including TNF?, in the sequence of events that result in severe tissue damage following an injury or inflammatory disease. Preclinical studies to date have suggested that blocking HMGB-1 may help protect animals from injury associated with many chronic and acute inflammatory diseases, and may reduce sepsis-related deaths.
Under the terms of the agreement, CTI will receive $12.5 million in upfront payments from MedImmune plus future undisclosed milestone payments and royalties on sales of any approved products resulting from the research. MedImmune will develop the commercial production process for any and all potential drug products. MedImmune will also fund a majority of the re-search and development activities, the level to which is subject to CTI's exercise of a co-promotion option for the lead anti-HMGB-1 candidate.
"MedImmune has made a strong commitment in the area of anti-inflammatory medicine, and we are extremely pleased to collaborate with the company in the emerging area of biologics," said Walter Newman, CTI's chief scientific officer. "Our alliance combines MedImmune's expertise in com-mercializing drug products with CTI's strong intellectual property in the area of HMGB-1, where we hold recently issued patents in the U.S. and Europe.
In addition, this agreement provides CTI with the opportunity for U.S. co-promotion of the products emanating from our collaboration. This is an important component in our plans to create a fully integrated biopharmaceutical company." In addition to today's agreement, MedImmune has also committed to participating in the next round of Critical Therapeutics' financing via its subsidiary, MedImmune Ventures, Inc.
About Critical Therapeutics, Inc.
Critical Therapeutics, Inc. is a privately held biopharmaceutical company focused on critical care medicine. CTI's mission is the discovery, development and commercialization of novel therapies for the treatment of acute trauma, cardiopulmonary disease and infectious and inflammatory ill-ness. The Company's current research and development portfolio includes the following thera-peutic targets: HMGB-1, a pro-inflammatory substance identified as a mediator of TNF-associated tissue damage; development of small molecule and vagal nerve stimulation approaches to treat inflammation; and CTI-01, a proprietary anti-inflammatory drug candidate currently in Phase I clinical trials. The Company is headquartered in Cambridge, Massachusetts. More in-formation about CTI is available at http://www.criticaltherapeutics.com
About MedImmune, Inc.
MedImmune is a leading biotechnology company focused on researching, developing and commercializing products to prevent or treat infectious disease, autoimmune disease and cancer. MedImmune actively markets four products, Synagis® (palivizumab), FluMist™ (influenza virus vaccine live, intranasal), Ethyol® (amifostine) and CytoGam® (cytomegalovirus immune globulin intravenous (human)), and has additional products in clinical testing. MedImmune employs approximately 1,700 people, is headquartered in Gaithersburg, Maryland, and has additional operations in Frederick, Maryland, as well as Pennsylvania, California, the United Kingdom and the Netherlands. For more information on MedImmune, and for full prescribing information on MedImmune's products, visit the company's website at http://www.medimmune.com.
This announcement may contain, in addition to historical information, certain forward-looking statements that in-volve risks and uncertainties. Such statements with respect to MedImmune reflect the current views of MedImmune's management and are based on certain assumptions. Actual results for MedImmune could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in MedImmune's filings with the U.S. Securities and Exchange Commission. MedImmune is developing several products for potential future marketing. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance were received, such products would ultimately achieve commercial success.